Table 1.
Baseline characteristics of patients with AML treated with 10-day decitabine and venetoclax
| Patient characteristics | Treatment-naïve patients | Previously treated patients | ||
|---|---|---|---|---|
| Newly Diagnosed AML (N=70) | Untreated Secondary AML (N=15)1 | Treated Secondary AML (N=28)2 | Relapsed or Refractory AML (N=55) | |
| Age, years | 72 [70–78] | 71 [68–76] | 70 [65–76] | 62 [43–73] |
| Age ≥ 70 years | 53 (76) | 10 (67) | 15 (54) | 19 (35) |
| Male sex | 35 (50) | 10 (67) | 19 (68) | 31 (56) |
| ECOG Performance Status | ||||
| 0–1 | 46 (66) | 9 (60) | 20 (71) | 42 (76) |
| ≥2 | 24 (34) | 6 (40) | 8 (29) | 13 (24) |
| WBC count, x109/L | 2∙9 [1∙8–4∙8] | 4∙3 [2∙0–6∙7] | 2∙0 [1∙0–5∙4] | 3∙6 [1∙6–6∙0] |
| Peripheral blood blasts, % | 10 [1–30] | 4 [0–27] | 8 [1–27] | 24 [3–58] |
| Bone marrow blasts, % | 45 [23–62] | 36 [18–61] | 32 [25–54] | 34 [22–64] |
| Diagnosis | ||||
| De novo | 55 (79) | 0 (0) | 0 (0) | 51 (93) |
| Therapy-related | 15 (21) | 1 (7) | 3 (11) | 4 (7) |
| ELN 2017 risk group | ||||
| Favorable | 18 (26) | 1 (7) | 4 (14) | 8 (15) |
| Intermediate | 8 (11) | 3 (20) | 3 (11) | 12 (22) |
| Adverse | 44 (63) | 11 (73) | 21 (75) | 35 (64) |
| ELN 2017 cytogenetic risk | ||||
| Favorable | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Intermediate | 36 (51) | 8 (53) | 14 (50) | 32 (58) |
| Adverse | 33 (47) | 7 (47) | 14 (50) | 23 (42) |
| Mutations | ||||
| NPM1 | 19 (27) | 1 (7) | 4 (14) | 12 (22) |
| FLT3-ITD/TKD | 14 (20) | 0 (0) | 2 (7) | 10 (18) |
| TP53 | 21 (30) | 5 (33) | 8 (29) | 16 (29) |
| RUNX1 | 9 (13) | 1 (7) | 10 (36) | 9 (16) |
| ASXL1 | 9 (13) | 3 (20) | 9 (32) | 5 (9) |
| IDH1/2 | 16 (23) | 2 (13) | 3 (11) | 11 (20) |
| K/NRAS | 14 (20) | 5 (33) | 7 (25) | 13 (24) |
| Prior therapies | 0 [0] | 0 [0] | 2 [1–2] | 2 [1–3] |
| Hypomethylator | 25 (89) | 25 (45) | ||
| (HMA)3 | 4 [4–12] | 3 [2–6] | ||
| No. of cycles | 20 (71) | 10 (18) | ||
| ≥4 cycles | 5 (18) | 42 (76) | ||
| Intensive | 3 (11) | 12 (22) | ||
| chemotherapy (IC) | 8 (29) | 18 (33) | ||
| HMA and IC | ||||
| Stem-cell transplantation | ||||
| Cytoreduction prior to start | 27 (39) | 4 (27) | 4 (14) | 12 (22) |
| Hydroxyurea only | 0 (0) | 1 (7) | 0 (0) | 3 (5) |
| Cytarabine only | 11 (16) | 2 (13) | 1 (4) | 4 (7) |
| Hydroxyurea and cytarabine | ||||
All results expressed as no. (%) or median [interquartile range], unless specified. ECOG = Eastern Cooperative Oncology Group; AML = acute myeloid leukemia. ELN = European LeukemiaNet; N/A = not applicable.
1.
Prior disorder in the untreated secondary AML group included MDS (n=7) and myeloproliferative neoplasms (n=2);
2.
Treated secondary AML patients had received prior therapy for preceding MDS/CMML but not for AML.
3.
Prior HMA included azacitidine in 31 patients, decitabine in 24 patients, and guadecitabine in 7 patients.